Status:
ENROLLING_BY_INVITATION
Biventricular Remodeling in Transcatheter Tricuspid Valve Replacement - Acute Hemodynamic Instability Study
Lead Sponsor:
Columbia University
Conditions:
Tricuspid Regurgitation
Heart Failure
Eligibility:
All Genders
18+ years
Brief Summary
TTVR-AHI is a multicenter, retrospective registry including heart failure patients displaying a severe and symptomatic tricuspid regurgitation (TR), deemed non-eligible to cardiac surgery and therefor...
Detailed Description
TTVR-AHI is an international, multicenter, retrospective registry collecting routine clinical and echocardiographic data, on top of a dedicated analysis of the preprocedural CT-scan using Laralab® sof...
Eligibility Criteria
Inclusion
- Patients implanted with TTVR: Evoque valve system (Edwards Lifesciences), and all other device in the setting of compassionate use And
- Patients presenting an AHI, defined by the need for inotrope and/or vasopressor support within 24 hours after the procedure due to hemodynamic instability (according to local investigator's judgement).
Exclusion
- Major procedural complication explaining hemodynamic situation (bleeding, tamponade, etc. )
- Patients started on inotrope/vasopressor either as part of a routine post-interventional protocol or preventively for "right ventricular (RV) support" without sign of hypoperfusion.
Key Trial Info
Start Date :
January 1 2026
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06954792
Start Date
January 1 2026
End Date
May 1 2026
Last Update
November 12 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Columbia University Medical Center
New York, New York, United States, 10032